# K942017: V-Primer

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Jul 6, 1994 after 71 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974089: Alloy Primer (1997), 5 descendants of its own
- K012436: Modification to Alloy Primer (2001), 2 descendants of its own
- K171226: Tokuyama Universal Bond (2017), 1 descendant of its own
- K251587: VITA VMLC Primer (2026), 0 descendants of its own
- K203760: Tokuyama Universal Bond II (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K942017
Methodology: https://510kreport.com/methodology